study of labetuzumab govitecan in participants with metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer; Colon Cancer; Rectal Cancer

Summary: the goal of this clinical study is to determine the dosing and safety of labetuzumab govitecan (formerly known as immu-130; hmn-14-sn38, antibody-drug conjugate) in participants with colorectal cancer.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed colorectal adenocarcinoma. * stage iv (metastatic) disease. * previously treated with at least one prior irinotecan-containing regimen for colorectal cancer. * adequate performance status (eastern cooperative oncology group (ecog) 0 or 1). * expected survival \> 6 months. * carcinoembryonic antigen (cea) plasma levels \> 5 ng/ml. * measurable disease by computed tomography (ct) or magnetic resonance imaging (mri). * at least 4 weeks beyond treatment (chemotherapy, immunotherapy and/or radiation therapy) or major surgery and recovered from all acute toxicities. * at least 2 weeks beyond corticosteroids. * adequate hematology without ongoing transfusional support (hemoglobin \> 9 g/dl, absolute neutrophil count (anc) \> 1,500 per mm\^3, platelets \> 100,000 per mm\^3). * adequate renal and hepatic function (creatinine ≤ 1.5 x iuln, bilirubin ≤ institutional upper limit of normal (iuln), aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 3.0 x iuln or 5 x iuln if know liver metastases). * otherwise, all toxicity at study entry ≤ grade 1 by national cancer institute common terminology criteria for adverse events (nci ctc) v4.0. exclusion criteria: * women who are pregnant or lactating. * women of childbearing potential and fertile men unwilling to use effective contraception during study until conclusion of 12-week post-treatment evaluation period. * individuals with gilbert's disease or known central nervous system (cns) metastatic disease. * individuals with cea plasma levels \> 1000 ng/ml must be approved in advance by the sponsor. * presence of bulky disease (defined as any single mass \> 10 cm in its greatest dimension). * individuals with active ≥ grade 2 anorexia, nausea or vomiting, and/or signs of intestinal obstruction. * individuals with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while individuals with other prior malignancies must have had at least a 3-year disease-free interval. * individuals known to be human immunodeficiency virus (hiv) positive, hepatitis b positive, or hepatitis c positive. * known history of unstable angina, myocardial infarction, or congestive heart failure present within 6 months or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy. * known history of clinically significant active chronic obstructive pulmonary disease (copd), or other moderate-to-severe chronic respiratory illness present within 6 months. * infection requiring intravenous antibiotic use within 1 week. * other concurrent medical or psychiatric conditions that, in the investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.

Keywords: previously treated metastatic colorectal cancer previously treated colon cancer previously treated rectal cancer